(56 days)
Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.
Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.
This is a 510(k) summary for a dental retraction cord (Stay-put impregnated), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of device performance against pre-defined acceptance criteria in the way a novel diagnostic or therapeutic device might.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this type of submission. The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an attempt to answer your questions based on the provided text, and where information is not available, I will state that:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Pathway: Substantial Equivalence to Predicate Device | Stay-put impregnated is substantially equivalent to Ultrapak E. |
| Material Composition: Impregnated retraction cord. | Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate. |
| Intended Use: Temporary retraction and hemostasis of the gingival margin. | Stay-put impregnated is indicated for the temporary retraction and hemostasis of the gingival margin. |
| Technical Characteristics: Similar to predicate device. | "The technical characteristics are similar to those found with the predicate device Ultrapak E." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of device performance evaluation as it would for a new diagnostic or therapeutic device. The submission focuses on demonstrating substantial equivalence based on material composition, intended use, and technical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental retraction cord, not an AI-powered diagnostic tool, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this 510(k) is primarily the established safety and effectiveness profile of the predicate device, Ultrapak E, as the new device is claiming substantial equivalence to it. No independent ground truth establishment for a novel performance claim is detailed.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device or a clinical trial with a training phase.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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